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MechanismViral proteins inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
A Phase 1a, Randomized, Double-blind Placebo-controlled Study to Evaluate Safety and Tolerability and to Characterize the Pharmacokinetic Profile of Single Ascending Doses of Fenretinide Oral Capsules in Healthy Adult Volunteers
The goal of this clinical trial is to learn about a single dose of fenretinide in healthy volunteers, in both a fasted and fed state. The main questions it aims to answer are: •How well is a single dose of fenretinide tolerated? AND •How is a single dose of fenretinide metabolized in healthy volunteers?
Participants will be asked to:
Remain confined in a clinical research unit for 5 days after dosing.
Provide blood samples for intense PK sampling and safety labs.
Fast for 10 hours prior to administration of study drug (fasted cohorts).
Consume a high fat meal prior to administration of study drug (fed cohort).
Return to the clinic for a single follow-up visit for safety assessments. Researchers will compare active fenretinide to placebo to see if fenretinide is more or less tolerable than placebo.
100 Clinical Results associated with Island Pharmaceuticals Ltd.
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100 Translational Medicine associated with Island Pharmaceuticals Ltd.